Comparing Six Different Methods to Obtain Expiratory Time ConstantNCT05827640
Expiratory Time Constant in Mechanically Ventilated Patients
An observational study of Comparing Six Different Methods to Obtain Expiratory Time Constant, run by East Slovak Institute for Cardiovascular Diseases at 1 site in Slovakia.
Trial summary
Determining expiratory time constants in mechanically ventilated patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Comparing Six Different Methods to Obtain Expiratory Time Constant
- What is being tested?
- data recording using conventional ventilation strategies (PCV and VCV)
- How many people
- 30 participants
- Where
- 1 siteSlovakia
- Study dates
- 15 Nov 2022to 30 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective cardiac surgery with extracorporeal circulation (mostly CABG or AVR).
Who may be able to join
None listed.
Who cannot join
- known pulmonary disease
- previous thoracic surgery
- poor preoperative cardiac status
Trial locations and contacts
1 site in 1 country.
Slovakia1 site
East Slovak Institute for Cardiovascular Diseases
Košice, 040 01
About this study
Official title: Determining Expiratory Time Constant in Mechanically Ventilated Patients
Determining expiratory time constants in mechanically ventilated patients
Read the detailed description
Adult patients (n = 30) undergoing elective cardiac surgery with extracorporeal circulation (ECC) were included. Patients were excluded from the study if they had any known lung disease or had previous thoracic surgery. After the surgery, all patients were transferred to the intensive care unit (ICU) and connected to well-established Servo-U (Maquet, Getinge AB, Solna, Sweden) mechanical ventilator. First, the ventilation mode was set to mandatory volume-controlled ventilation (VCV) for 15 minutes. After that, mandatory pressure-controlled ventilation (PCV) for another 15 minutes was commenced. All patients were in supine position, sedated and paralyzed using continuous infusion of propofol and atracurium with no spontaneous breathing efforts. During VCV, an end-inspiratory pause (TPAUSE 10%) has been added to obtain inspiratory plateau pressure (P PLAT) under static conditions. Respiratory variables in VCV for all patients were as follows: PEEP 6 - 9 cmH 2 O depending on the local protocol, protective tidal volume (Vt) of 7 ml/kg/PBW, T PAUSE was set to 10%, I:E ratio of 1:2, rise time 5% and the respiratory rate was 14 breaths/min. After 15 minutes, VCV was changed to PCV with the same ventilator setting with inspiratory pressure set in the way to best match the Vt during the VCV. ARDSNet tables were used to determine PBW for all patients.
A novel device enabling data acquisition (Dr. Wave, Quadrus Medical Technologies, NY, White Plains, USA) has been connected to the Servo-U ventilator after admission to the ICU to record flow, pressure, and volume waveforms. All data in the study were derived from measurements and calculations from this device and included: Peak Inspiratory Pressure (PIP), PPLAT, PEEP, expiratory tidal volume (Vt) respiratory system compliance (C RS ), airway resistance (RTOT) and the peak expiratory flow rate (PEFR).
Based on obtained data of flow, volume and pressure during PCV and VCV, six different methods to determined expiratory time constant were examined
- Being tested
- data recording using conventional ventilation strategies (PCV and VCV)
- Keywords
- expiratory time constant, mechanical ventilation, exhalation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data recording using conventional ventilation strategies (PCV and VCV)Other
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Expiratory time constant
Six different methods to assess expiratory time constants in mechanically ventilated patients
Measured: 3 months
Secondary outcomes (1)
Validity of expiratory time constant definition
To prove if three time constant correspond to actual first time constant multiplied by the factor of 3
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start15 Nov 2022
- Primary completion30 Jan 2023
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comparing Six Different Methods to Obtain Expiratory Time ConstantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Slovak Institute for Cardiovascular Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filip Depta MD, East Slovak Institute for Cardiovascular Diseases
- Investigators
- Dušan Rybár, PhD, Study director, East Slovak Institute for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827640
- Sponsor's protocol ID
- www.vusch.sk
- Status last verified
- Apr 2023
- First submitted
- 12 Apr 2023
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Expiratory Time Constant in Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT05827640
- Acronym / sponsor ID
- www.vusch.sk
- Keywords
- expiratory time constant, mechanical ventilation, exhalation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- East Slovak Institute for Cardiovascular DiseasesUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determining expiratory time constants in mechanically ventilated patients
Detailed description
Adult patients (n = 30) undergoing elective cardiac surgery with extracorporeal circulation (ECC) were included. Patients were excluded from the study if they had any known lung disease or had previous thoracic surgery. After the surgery, all patients were transferred to the intensive care unit (ICU) and connected to well-established Servo-U (Maquet, Getinge AB, Solna, Sweden) mechanical ventilator. First, the ventilation mode was set to mandatory volume-controlled ventilation (VCV) for 15 minutes. After that, mandatory pressure-controlled ventilation (PCV) for another 15 minutes was commenced. All patients were in supine position, sedated and paralyzed using continuous infusion of propofol and atracurium with no spontaneous breathing efforts. During VCV, an end-inspiratory pause (TPAUSE 10%) has been added to obtain inspiratory plateau pressure (P PLAT) under static conditions. Respiratory variables in VCV for all patients were as follows: PEEP 6 - 9 cmH 2 O depending on the local protocol, protective tidal volume (Vt) of 7 ml/kg/PBW, T PAUSE was set to 10%, I:E ratio of 1:2, rise time 5% and the respiratory rate was 14 breaths/min. After 15 minutes, VCV was changed to PCV with the same ventilator setting with inspiratory pressure set in the way to best match the Vt during the VCV. ARDSNet tables were used to determine PBW for all patients.
A novel device enabling data acquisition (Dr. Wave, Quadrus Medical Technologies, NY, White Plains, USA) has been connected to the Servo-U ventilator after admission to the ICU to record flow, pressure, and volume waveforms. All data in the study were derived from measurements and calculations from this device and included: Peak Inspiratory Pressure (PIP), PPLAT, PEEP, expiratory tidal volume (Vt) respiratory system compliance (C RS ), airway resistance (RTOT) and the peak expiratory flow rate (PEFR).
Based on obtained data of flow, volume and pressure during PCV and VCV, six different methods to determined expiratory time constant were examined
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective cardiac surgery with extracorporeal circulation (mostly CABG or AVR).
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- known pulmonary disease
- previous thoracic surgery
- poor preoperative cardiac status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| data recording using conventional ventilation strategies (PCV and VCV)no intervention | Other | – |
Primary outcome
Expiratory time constant
Time frame: 3 months
Six different methods to assess expiratory time constants in mechanically ventilated patients
1 secondary outcome
Validity of expiratory time constant definition
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dušan Rybár, PhD study director
East Slovak Institute for Cardiovascular Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Comparing Six Different Methods to Obtain Expiratory Time Constant, run by East Slovak Institute for Cardiovascular Diseases at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expiratory time constant (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.